FDA.reportPublic FDA data

CONSTIPATION

Manufacturer
Natural Creations, Inc. | OHM Pharma, Inc.
Effective date
2020-01-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:11:56

Label at a glance#

ProductCONSTIPATION
Active ingredientMAGNESIUM CARBONATE, MAGNESIUM CHLORIDE, HORSE CHESTNUT, POTASSIUM ALUM, ALUMINUM OXIDE, BRYONIA ALBA ROOT, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (HPUS*): Magnesium Carbonicum 4X, Magnesium Muriaticum 4X, Aesculus Hippocastanum 12X, Alumen 12X, Alumina 12X, Bryonia Alba 12X, Nux Vomica 12X, Silicea 12X

OTC - PURPOSE SECTION

USES: Temporarily relieves great straining, large, dry, hard, knotty stools, &/or other symptoms of constipation.**

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center.

INDICATIONS & USAGE SECTION

USES: Temporarily relieves great straining, large, dry, hard, knotty stools, &/or other symptoms of constipation.**

WARNINGS SECTION

WARNING:

  • Consult a physician for use in children under 12 years of age. 
  • IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water.

OTC - QUESTIONS SECTION

Questions & Comments?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

REFERENCES SECTION

*The  letters “HPUS” indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

**These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 43406-0610-1

CONSTIPATION

HOMEOPATHIC

1 fl oz (30 mL) / 20% Alcohol

UPC: 877730001030

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43406-0610-12022-01-28C16284748780-1d6a99b39-6c60-a426-e053-dadaa90af4c2CONSTIPATION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0610-1CONSTIPATION30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0610CONSTIPATION (MAGNESIUM CARBONATE, MAGNESIUM CHLORIDE, HORSE CHESTNUT, POTASSIUM ALUM, ALUMINUM OXIDE, BRYONIA ALBA ROOT, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE) LIQUID [NATURAL CREATIONS, INC.]2Legacy NDC, 1 package rows20200103_712837b8-0550-4e60-a2ad-cf2a589e70ca.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43406-061043406-0610-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM CARBONATE0E53J927NAACTIB
MAGNESIUM CHLORIDE02F3473H9OACTIB
HORSE CHESTNUT3C18L6RJAZACTIB
POTASSIUM ALUM1L24V9R23SACTIB
ALUMINUM OXIDELMI26O6933ACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4584bf89-85ac-4f88-9343-bebf43cbdea2712837b8-0550-4e60-a2ad-cf2a589e70ca2013-01-21WarningsExact identifier
spl set id: 712837b8-0550-4e60-a2ad-cf2a589e70ca

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.